Change From Baseline in the Minnesota Living With Heart Failure Questionnaire (MLHF- Q) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

The MLHF-Q contains 21 questions with answers ranging from 0 (no) to 5 (very much). The final score ( 0 to 105) is the sum of the points for the 21 questions. A higher score indicates a worse quality of life.

Change From Baseline in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

HGT-REP-060 was designed to provide patients who participated in TKT028 an additional 52 weeks of treatment with Replagal at the standard dose of 0.2 mg/kg EOW to assess the effect of continued Replagal therapy on long-term safety and clinical outcomes for this patient population.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Complete all study requirements and assessments for Study TKT028 less than 30 days (+/- 7 days) prior to the first dose in this extension protocol

Voluntarily signed an Institutional Review Board/Independent Ethics Committee- approved informed consent form after all relevant aspects of the study have been explained and discussed.

Has received and tolerated at least 80% of the total planned Replagal infusions in Study TKT028

Female patients of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study and must have a negative pregnancy test at the time of study entry and as required throughout participation in study

Exclusion Criteria:

Has received treatment with any investigational drug (other than Replagal) or device within 30 days prior to study entry.

Is unable to comply with the protocol, (eg, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the Investigator

Has any safety or medical issues, as assessed by the Investigator, that contraindicate participation in the study (eg, has experienced an adverse reaction to treatment with Replagal or has a known hypersensitivity to any of the components of Replagal

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124643